Major nonformance finding was given during a closing meeting of a ISO9001 certification audit

Big Jim

Super Moderator
#61
9.3.2 use the statement "taking into consideration", I believe, there's some flexibility on this. ISO/TS 9002: 2016 has also this statement: "It is not required that all the inputs to management review be addressed at one time, but instead they may be addressed during sequenced management reviews".
My view of the guidance from 9002 is that not all of management review has to be in one meeting. Some organizations choose to cover all the requirements in multiple meetings and that would be OK as long as all the requirements are covered in that one multi-session management review. This has been commonly practiced in the past. There is nothing new here.
 
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tony s

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#62
I believe the guidance wants to veer away from the traditional way of convening a "special one-time a year meeting" where most organizations in the past, even in the present, practice to demonstrate conformity with the requirement. Hence the initial statement in 9002 clause 9.3.1 says: "The intent of this subclause is to ensure that top management conduct management reviews".

Another statement, in 9002, to support the "sequenced" management reviews mentioned this: "The timing of management reviews can be scheduled to coincide with other business activities (e.g. strategic planning, business planning, annual meetings, operations meetings, other management system standards’ reviews) to add value and to avoid redundant multiple meetings".

The OP's management review that was done in October 2018 would certainly be sequenced and the evidence/s that was/were not presented before can be made available on the next reviews.

Anyway, great discussion Big Jim. This might be a YMMV topic but I learned a lot. :agree:
 

Big Jim

Super Moderator
#63
Olive branch accepted.

Keep in mind that nowhere in the standard is it said that management review needs to be a meeting. It speaks of management review, not management review meetings. Perhaps that is fodder for another topic another time.
 

tony s

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#64
Keep in mind that nowhere in the standard is it said that management review needs to be a meeting. It speaks of management review, not management review meetings. Perhaps that is fodder for another topic another time.
I have a client before, a customs brokerage company sometime in the 1st-half of 2008. Since most of the key personnel are out on field, we decided to just send through email the reports and other information as per clause 5.6 of the 2000 version (2008 was not yet released then). The QMR, who is also a COO (child of the owner), then collates these information and reports to his father. During their certification audit, knowing that CB auditors will have issues with the approach, the QMR presented the reports, including the responses and directions given by his father upon review, through his laptop. Scratching his head, the CB auditor acceded to the approach and did not raise an issue against 5.6.
 

RoxaneB

Super Moderator
Super Moderator
#66
Just about every auditor we have had specifically asks to see the management review minutes. It's really frustrating.
I attribute that to training and an adherence to the "that's the way we've always done" approach. It can be frustrating and I shake my head at the irony (i.e., people who look for a system of improvement fail to improve their own technique).
 

Sidney Vianna

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Admin
#67
Anyway, I hope, with the knowledgeable people here at the Cove, that the statement "Records from management reviews shall be maintained" placed at 5.6.1-General of 2008 is not similar with "The organization shall retain documented information as evidence of the results of management reviews" placed at 9.3.3-Management review outputs of the 2015.
I confess that I have not compared the two, but what is the difference between them? What makes them dissimilar?
 

Randy

Super Moderator
#68
I confess that I have not compared the two, but what is the difference between them? What makes them dissimilar?
9K08 had this, and it's all that was required to be documented..."Records from management reviews shall be maintained (see 4.2.4)." What was required to be recorded was ambiguous at best.

9K15 has this..... "The organization shall retain documented information as evidence of the results of management reviews." You figure it out.

The TC 176 APG hasn't any guidance and there sure isn't anything I can find in ANAB rules.
 

Sidney Vianna

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#69
Actually the ISO 9001 APG does have guidance on management review. It states:

ISO 9001 requires top management to review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review could be carried out at a separate meeting but this is not a requirement of the standard.

There are many ways in which Top Management can review the quality management system, such as receiving and reviewing a report generated by the management representative or other personnel, electronic communication, or as part of regular management meetings where issues such as budgets and targets are also discussed.

The management review is a process that should be conducted and audited utilizing the process approach. Organizations need to be able to demonstrate that they have evaluated the effectiveness of actions taken to address risks and opportunities during management review; consequently auditors will be able to obtain objective evidence on the use of this approach.
ISO 9001 specifies a number of inputs to the management review process and these topics need to be addressed; however, these are not the only subjects that can be included in a review. It is also acceptable not to address them individually or simultaneously but as part of an overall review of the business. Auditors should be aware that the inputs could be in many forms such as reports, trend charts and so on.

As outputs from the management review process, there should be evidence of decisions regarding:
• changes to the quality policy and objectives,​
• plans and possible actions for improvements,​
• change of resources,​
• revised business plans,​
• budgets.​

The outputs may not be only related to improvements or changes, but could also include decisions on other important issues, such as plans to introduce new products. Documented information on management reviews is required, but the format of this is not specified; minutes of meetings are the most common type, but electronic records, statistical charts, presentations etc. could be acceptable types.

The management review process might also include elements of quality management system planning, where changes to processes and systems are being considered.

Where this is the case, the auditors should review whether or not the following points have been considered:
• Will changes to the management system, or the business as a whole, have an impact on other parts of the system or business?​
• Are proposed changes evaluated before implementation?​
• In preparing strategic plans, are issues such as those in clause 4 “Context of the organization” of the standard considered?​
• Are the controls needed identified before the outsourcing of a process is begun?​
The management review process should not be an exercise carried out solely to satisfy the requirements of the standard and the auditors; it should be an integral part of the organization’s business management process. An overall management review is a complex process carried out at various levels in the organization. It will always be a two-way process, generated by top management with inputs from all levels in the organization. These activities could vary from daily, weekly, monthly, organizational unit meetings to simple discussions or reports. Auditors should look for evidence that the inputs and outputs of the management review process are relevant to the organization’s size and complexity and that they are used to improve the business. Auditors should also consider how the organization’s management is structured and how the management review process is used within this structure.
 

tony s

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#70
I confess that I have not compared the two, but what is the difference between them? What makes them dissimilar?
I believe, aside from the structure of the statements as highlighted by Randy, the change in the location of the statement requiring records implies a different intent. 2008's statement was in General while 2015 placed it in the Output clause.

IMHO, this subtle change promotes an "output oriented" way of looking at the management review process. It could be the reason why the APG Guidance on Auditing Management Review mentioned this:
The management review is a process that should be conducted and audited utilizing the process approach.
 
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